البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
LIDOCAINE HYDROCHLORIDE
HIKMA CANADA LIMITED
N01BB02
LIDOCAINE
10MG
SOLUTION
LIDOCAINE HYDROCHLORIDE 10MG
BLOCK/INFILTRATION
15G/50G
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0101280004; AHFS:
APPROVED
2014-03-04
Page 1 of 29 PRESCRIBING INFORMATION LIDOCAINE HYDROCHLORIDE INJECTION USP 1% lidocaine hydrochloride (10 mg/mL) 2% lidocaine hydrochloride (20 mg/mL) For Infiltration and Nerve Block Local Anesthetic Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, Ontario L5R 3P9 Date of Preparation: April 22, 2022 Submission control no. 262671 Page 2 of 29 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION................................................................................ 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 11 DRUG INTERACTIONS.......................................................................................................... 13 DOSAGE AND ADMINISTRATION ..................................................................................... 15 OVERDOSAGE ........................................................................................................................ 19 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 20 STORAGE AND STABILITY ................................................................................................. 22 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING..................................................... 24 PART II: SCIENTIFIC INFORMATION ............................................................................... 25 PHARMACEUTICAL INFORMATION ................ اقرأ الوثيقة كاملة